Application 021667
- Type
- NDA
- Sponsor
- EMMAUS MEDCL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUTRESTORE | L-GLUTAMINE | FOR SOLUTION;ORAL | 5GM/PACKET | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021667-001 | NUTRESTORE | L-GLUTAMINE | 5GM/PACKET | FOR SOLUTION / ORAL | RLD | 2004-06-10 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021667-001 | NUTRESTORE | 5GM/PACKET | FOR SOLUTION / ORAL | RLD | 2004-06-10 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021667-001 | NUTRESTORE | 5GM/PACKET | FOR SOLUTION / ORAL | RLD | 2004-06-10 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021667-001 | NUTRESTORE | 5GM/PACKET | FOR SOLUTION / ORAL | RLD | 2004-06-10 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021667-001 | NUTRESTORE | 5GM/PACKET | FOR SOLUTION / ORAL | RLD | 2004-06-10 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| L-glutamine | L-GLUTAMINE | Camber Pharmaceuticals, Inc. | 4d99b233-992f-4adb-aaab-ef0021a3807f | 2026-06-10 | Adverse reactions | L-GLUTAMINE |
| L-glutamine | L-GLUTAMINE | Renova Pharmaceuticals LLC | 3f324755-159b-40ee-a9f4-e6800558acf3 | 2026-05-27 | Adverse reactions | L-GLUTAMINE |
| L-Glutamine | L-GLUTAMINE | ANI Pharmaceuticals, Inc. | bb4ec712-14b7-47e3-8cb9-c71922712e55 | 2025-08-07 | Adverse reactions | L-GLUTAMINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.